Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555952
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
MegaNatural BP GSE on Blood Pressure and Cardiometabolic Risk Factors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
MegaNatural BP GSE on Blood Pressure and Cardiometabolic Risk Factors
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GSEBP
Brief Summary:
Inflammation and stressors can interfere with the function of the lining of blood vessels and insulin activity therefore investigators are aiming to see how the Grape seed Extract GSE called MegaNatural BP can help with limiting the effects of these factors This research will study the effects of taking 150mg of MegaNatural BP GSE per day on blood pressure levels along with influences on heart health through assessing the function of the blood vessel lining and levels of inflammation
Detailed Description:
This is a research study to determine if an extract made from grape seeds might help control blood pressure Previous research studies have found that taking this extract as a daily supplement at 300 mg per day in a capsule or a beverage may lower blood pressure in individuals with elevated blood pressure levels The commercial name of this supplement is called MegaNatural BP The principal investigators of this study were part of the original research studies on GSE both MegaNatural BP GSE and MegaNatural Gold GSE They are now interested to determine if a lower amount of the grape seed extract might be effective in lowering peoples blood pressure when its elevated There is also some earlier information suggesting the GSE may influence how well insulin works in peoples body This may be helpful for individuals with metabolic conditions like the early stages of pre-diabetes
The study will last for six weeks All participants will visit the Clinical Nutrition Research Center CNRC seven times over the course of the study These visits include a screening visit two ambulatory blood pressure device fitting visits and four study day visits throughout the six weeks Blood will be collected to assess insulin activity measures during subject visits to the CNRC The flexibility of subjects blood vessels will be measured using an ultrasound technique Flexibility of vessels is important for blood pressure regulation and GSE has been known to help them become more flexible
SCREENING VISIT
A subjects eligibility for the study is based on the list inclusion and exclusion criteria Clinical Research Coordinators will determine if the subject qualifies for the study at the Screening Visit by the following measurements
General measurements height weight body composition and body temperature
Fasting blood glucose from a finger prick
Blood pressure
Pregnancy test for women under the age of 60 During the visit the subject will be asked to complete a questionnaire or answer questions related to their health dietary habits and physical activity history Based on the results of the blood sugar questionnaires measurements and evaluation of their health the subject may meet the criteria and be invited to participate in the study
PRE-STUDY PRE-INTERVENTION VISIT which may be performed at the same or different day as screening visit The Pre-Study visit lasts 30-45 minutes and the subject will meet with one of the investigators who will provide detailed instructions on procedures of the study Blood pressure devices and how to prepare for each of the study days The subject will be trained on all study procedures including but not limited to foods to avoid during the study medicationssupplements to avoid food diary recording and GI-tract diary recording fasting overnight The participants study dates will be scheduled and they will be provided a study booklet including the study calendar and all instructions covered at the Pre-Study Visit
MedicationsSupplements If the subject is taking any medications or supplements that do not interfere with the study or have been OKd by study staff they will take those as instructed by their doctor and will record in the diary Clinical Research Coordinators will train the subject on what foods or supplements are OK and NOT OK during the study at the Pre-Study Visit
Self-Characteristics and Dietary Surveys During this visit participants will be asked to complete online surveys that cover usual gastrointestinal GI symptoms and a 24-hour food recall
Ambulatory Blood Pressure Device Fitting and Baseline BP measurement Day 0 At the pre-study visit or another scheduled day at the participants convenience the subject will be fitted with an ambulatory blood pressure device ABPD for collection of blood pressure for 24 h during their wake and sleep time This is the most accurate assessment of their true blood pressure They will begin wearing the device once fitted until returning the next day which they will need to return to the clinic As part of the 24 h device wearing investigators will ask that the subject keeps a sleep wake exercise eating diary This helps the clinic understand the subjects data and when the blood pressure increases and decreases
The subject will be given a frozen dinner to consume before they start fasting This meal will be the same meal that is consumed before Visit 5
STUDY DAY VISITS
Study Visit 1 Day 1 Procedures
1 Staff collects study materials from participant
1 Blood pressure monitor Confirm data
2 Diary and provide 24 h recall ASA24h
2 Confirmation the subject is ready to go for their study day by interviewdiscussion with study staff
1 Fasted overnight for 10-12 hours
2 Had a usual night of sleep
3 Avoided alcohol and vigorous physical activity 24 hours before study day After confirming the subject is ready for their study day staff will proceed to measure their weight check their vital signs blood pressure heart rate and temperature as well as measure their fasting blood glucose from a finger prick ultrasound for FMD body composition and collect a blood sample
Ultrasound for Flow mediated dilation FMD FMD is a procedure to test the flexibility of brachial vessels The researcher will use an ultrasound machine to visualize the artery in the subjects arm The sonographer who will visual the arm artery and conduct the procedure will add sensors to the subjects body to track their heart rate and inflate a blood pressure cuff for 5 minutes on their arm before releasing to see and measure by ultrasound how flexible the arteries are This will take about 30 minutes The procedure will take place again 120 min after breakfast
Blood collection The subject will see the Licensed Health Care Provider LHCP for blood sample collection The subject has the choice of an intravenous catheter or multiple butterfly sticks There will be eight blood draws total Once the fasting blood draw is collected investigators will provide the subject with a capsule and then 5 min later a breakfast in the form of a nutritionally complete liquid drink Ensure Blood samples will be collected over the next 3 hours via a multi-sampling protocol The subject will then be provided capsules for daily intake over two weeks until the next visit
Other procedures Every effort will be made to ensure the subjects safety while participating in this study
Anthropometrics Researchers will measure the subjects height as well as weight and body composition Researchers will repeat the weight measurements as shown in the table The subject will be asked to wear light comfortable clothing when coming to the screening and study related visits
Vital signs Researchers will check the subjects blood pressure heart rate and body temperature using standard clinic devices
Demographic questionnaire health and medication questionnaire Subjects will be asked to provide personal information such as name date of birth race etc They will also be asked to answer questions about demographics health medical history and the medications they take
Study Visits 2 and 3 Procedures- Pick Up Visit Visit 2 two weeks after Visit 1 and Visit 3 two weeks after Visit 2 will involve a weight check blood draw for compliance and supplement refill and reconciliation
Study Visit 4- ABPD Fitting Procedure One day before Visit 5 the subject will be expected to come into the CNRC to be fitted with an ABPD The subject will wear the ABPD day and night and fill out the 24 hour log until returning to the clinic for the final visit 5 the next day
The subject will be given a frozen dinner to consume before they start fasting This meal is the same as PreStudy or before Visit 1
Study Visit 5 Procedures Visit 5 two weeks after Visit 3 is the final study day visit This visit will take place the day after Visit 4 This visit will be exactly the same as Visit 1 except the LMTT will include a capsule of the dietary regimens placebo or MN-BP that are randomly assigned to participants After all study procedures are completed the participant will be given a take-home snack and compensation will be issued
The study will last for six weeks All participants will visit the Clinical Nutrition Research Center CNRC seven times over the course of the study These visits include a screening visit two ambulatory blood pressure device fitting visits and four study day visits throughout the six weeks Blood will be collected to assess insulin activity measures during subject visits to the CNRC The flexibility of subjects blood vessels will be measured using an ultrasound technique Flexibility of vessels is important for blood pressure regulation and GSE has been known to help them become more flexible
SCREENING VISIT
A subjects eligibility for the study is based on the list inclusion and exclusion criteria Clinical Research Coordinators will determine if the subject qualifies for the study at the Screening Visit by the following measurements
General measurements height weight body composition and body temperature
Fasting blood glucose from a finger prick
Blood pressure
Pregnancy test for women under the age of 60 During the visit the subject will be asked to complete a questionnaire or answer questions related to their health dietary habits and physical activity history Based on the results of the blood sugar questionnaires measurements and evaluation of their health the subject may meet the criteria and be invited to participate in the study
PRE-STUDY PRE-INTERVENTION VISIT which may be performed at the same or different day as screening visit The Pre-Study visit lasts 30-45 minutes and the subject will meet with one of the investigators who will provide detailed instructions on procedures of the study Blood pressure devices and how to prepare for each of the study days The subject will be trained on all study procedures including but not limited to foods to avoid during the study medicationssupplements to avoid food diary recording and GI-tract diary recording fasting overnight The participants study dates will be scheduled and they will be provided a study booklet including the study calendar and all instructions covered at the Pre-Study Visit
MedicationsSupplements If the subject is taking any medications or supplements that do not interfere with the study or have been OKd by study staff they will take those as instructed by their doctor and will record in the diary Clinical Research Coordinators will train the subject on what foods or supplements are OK and NOT OK during the study at the Pre-Study Visit
Self-Characteristics and Dietary Surveys During this visit participants will be asked to complete online surveys that cover usual gastrointestinal GI symptoms and a 24-hour food recall
Ambulatory Blood Pressure Device Fitting and Baseline BP measurement Day 0 At the pre-study visit or another scheduled day at the participants convenience the subject will be fitted with an ambulatory blood pressure device ABPD for collection of blood pressure for 24 h during their wake and sleep time This is the most accurate assessment of their true blood pressure They will begin wearing the device once fitted until returning the next day which they will need to return to the clinic As part of the 24 h device wearing investigators will ask that the subject keeps a sleep wake exercise eating diary This helps the clinic understand the subjects data and when the blood pressure increases and decreases
The subject will be given a frozen dinner to consume before they start fasting This meal will be the same meal that is consumed before Visit 5
STUDY DAY VISITS
Study Visit 1 Day 1 Procedures
1 Staff collects study materials from participant
1 Blood pressure monitor Confirm data
2 Diary and provide 24 h recall ASA24h
2 Confirmation the subject is ready to go for their study day by interviewdiscussion with study staff
1 Fasted overnight for 10-12 hours
2 Had a usual night of sleep
3 Avoided alcohol and vigorous physical activity 24 hours before study day After confirming the subject is ready for their study day staff will proceed to measure their weight check their vital signs blood pressure heart rate and temperature as well as measure their fasting blood glucose from a finger prick ultrasound for FMD body composition and collect a blood sample
Ultrasound for Flow mediated dilation FMD FMD is a procedure to test the flexibility of brachial vessels The researcher will use an ultrasound machine to visualize the artery in the subjects arm The sonographer who will visual the arm artery and conduct the procedure will add sensors to the subjects body to track their heart rate and inflate a blood pressure cuff for 5 minutes on their arm before releasing to see and measure by ultrasound how flexible the arteries are This will take about 30 minutes The procedure will take place again 120 min after breakfast
Blood collection The subject will see the Licensed Health Care Provider LHCP for blood sample collection The subject has the choice of an intravenous catheter or multiple butterfly sticks There will be eight blood draws total Once the fasting blood draw is collected investigators will provide the subject with a capsule and then 5 min later a breakfast in the form of a nutritionally complete liquid drink Ensure Blood samples will be collected over the next 3 hours via a multi-sampling protocol The subject will then be provided capsules for daily intake over two weeks until the next visit
Other procedures Every effort will be made to ensure the subjects safety while participating in this study
Anthropometrics Researchers will measure the subjects height as well as weight and body composition Researchers will repeat the weight measurements as shown in the table The subject will be asked to wear light comfortable clothing when coming to the screening and study related visits
Vital signs Researchers will check the subjects blood pressure heart rate and body temperature using standard clinic devices
Demographic questionnaire health and medication questionnaire Subjects will be asked to provide personal information such as name date of birth race etc They will also be asked to answer questions about demographics health medical history and the medications they take
Study Visits 2 and 3 Procedures- Pick Up Visit Visit 2 two weeks after Visit 1 and Visit 3 two weeks after Visit 2 will involve a weight check blood draw for compliance and supplement refill and reconciliation
Study Visit 4- ABPD Fitting Procedure One day before Visit 5 the subject will be expected to come into the CNRC to be fitted with an ABPD The subject will wear the ABPD day and night and fill out the 24 hour log until returning to the clinic for the final visit 5 the next day
The subject will be given a frozen dinner to consume before they start fasting This meal is the same as PreStudy or before Visit 1
Study Visit 5 Procedures Visit 5 two weeks after Visit 3 is the final study day visit This visit will take place the day after Visit 4 This visit will be exactly the same as Visit 1 except the LMTT will include a capsule of the dietary regimens placebo or MN-BP that are randomly assigned to participants After all study procedures are completed the participant will be given a take-home snack and compensation will be issued
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None